3D MEDICINES(01244): ENVIDA is designated as an orphan drug for the treatment of gastric cancer and gastroesophageal junction cancer.
Sinopharm Di Medical Co., Ltd. (01244) announced that its commercialized product Envida (trade name: Envorlicks monoclonal antibody injection, original research code: KN035) has officially been granted orphan drug qualification for indications of gastric cancer and gastroesophageal junction cancer. This is the third orphan drug indication successfully approved for Envida following indications for bile duct cancer and soft tissue sarcoma.
3D MEDICINES (01244) announced that its commercial product, Envida (generic name: Enrolizumab Injection, original research code: KN035) has officially obtained orphan drug designation for the indications of gastric cancer and gastroesophageal junction cancer. This is the third orphan drug indication successfully approved for Envida following cholangiocarcinoma and soft tissue sarcoma indications.
The approval was based on the results of a phase II clinical study conducted by the company on Envida for advanced gastric/esophageal gastroesophageal junction adenocarcinoma, which showed a clear anti-tumor effect with an objective response rate of 60% when used in combination with the FOLFOX regimen. The disease control rate was as high as 100%, and it demonstrated good safety and tolerability, with no adverse events leading to treatment cessation or death.
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